Aficamten

Cytokinetics and Bayer form exclusive licensing deal for aficamten in Japan, focusing on hypertrophic cardiomyopathy (HCM). The agreement includes €50 million upfront, potential €90 million in milestones, and up to €490 million in commercial milestone payments, plus tiered royalties on Japanese sales. Bayer will conduct Phase 3 trials for obstructive HCM, while Cytokinetics expands ACACIA-HCM and CEDAR-HCM trials into Japan.

Cytokinetics presented new post-hoc analyses of GALACTIC-HF, showing omecamtiv mecarbil's efficacy in reducing heart failure risks in high-risk patients, including older adults and those with ventricular arrhythmias. The treatment effect was consistent across age groups and reduced the primary outcome risk in severe heart failure patients. Omecamtiv mecarbil also showed safety regarding ventricular arrhythmias and potential benefits for those with severely reduced LVEF.

Milind Desai, MD, MBA, discusses the results of the Risk Evaluation and Mitigation Strategy (REMS) program for mavamecten, showing low incidence of ejection fraction drop and heart failure hospitalization. Desai also highlights ongoing advancements in hypertrophic cardiomyopathy treatment, including new drugs and potential use of artificial intelligence.

Cytokinetics presented new post-hoc analyses of GALACTIC-HF, showing omecamtiv mecarbil reduced risk of adverse cardiac outcomes in severe heart failure patients across age groups, with significant risk reductions in both <65 and ≥65 years, and potential benefits in reducing ventricular arrhythmia risk.

RTW Biotech Opportunities Ltd's portfolio company, Corxel Pharmaceuticals, has had its new drug application for Aficamten accepted by China’s National Medical Products Administration. Aficamten treats obstructive hypertrophic cardiomyopathy, affecting 130,000 to 330,000 patients in China. The drug also received breakthrough therapy designation from the US FDA. Corxel was founded by RTW Investments in 2019.

CORXEL Pharmaceuticals, an RTW Biotech Opportunities portfolio company, has had its new drug application for Aficamten, a selective small molecule cardiac myosin inhibitor, accepted by China's NMPA for treating obstructive hypertrophic cardiomyopathy (HCM). Aficamten has received Breakthrough Therapy Designation from both the FDA and NMPA. HCM affects approximately 132,000-330,000 diagnosed and 748,000-1,870,000 undiagnosed patients in China.

RTW Biotech Opportunities Ltd's portfolio company, Corxel Pharmaceuticals, has had its new drug application for Aficamten accepted by China's National Medical Products Administration. Aficamten treats obstructive hypertrophic cardiomyopathy and has received breakthrough therapy designation from the US FDA. Corxel was founded by RTW Investments in 2019.

Cytokinetics announces first dosing in Phase 1 clinical study of CK-089, a fast skeletal muscle troponin activator, targeting muscular dystrophy and impaired muscle function.

Cytokinetics updates on cardiac myosin modulation programs, including NDA submission for aficamten, and plans for COMET-HF and AMBER-HFpEF trials, aiming to build a specialty cardiovascular franchise.

Cytokinetics updates on cardiac myosin modulation programs and global commercial launch readiness for aficamten, including NDA submission to FDA in Q3 2024, COMET-HF Phase 3 trial of omecamtiv mecarbil starting Q4 2024, AMBER-HFpEF Phase 2 trial of CK-586 also starting Q4 2024, and preparations for potential aficamten approval and launch in 2025, alongside the launch of the unbranded disease awareness campaign 'HCM Beyond The Heart'.